Catheter securement devices

ABSTRACT

Described herein are catheter securement devices that can be used to secure catheters, catheter hubs and ether medical devices to the body of a patient. The catheter securement devices can include an adhesive pad and engagement tabs with a slide locking feature. Adaptors can be used to provide suture tabs to catheters that lack suture tabs.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/588,515 entitled “Designs and Methods forCatheter Securement Devices” and filed Jan. 19, 2012, and U.S.Provisional Patent Application Ser. No. 61/652,589 entitled “SlidingLock Devices for Catheter Securement”, and filed May 29, 2012, all ofwhich are hereby incorporated by reference for all purposes.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The inventions relate generally to devices for securing medical devicesto a patient's body. More specifically, the inventions relate to devicesfor securing catheters, tubing or medical lines to a patient's skin.

BACKGROUND

Catheters, tubing and/or medical lines can be used to introduce fluids,medications or medical devices directly into the patient or to withdrawfluids from the patient. Often, it becomes desirable to maintain suchcatheterization over an extended period of time during the treatment ofa patient. In order to keep the catheter, tubing or other medical lineproperly positioned for the duration of treatment, the catheter, tubingor medical line can be secured to the patient in a variety of ways. Forexample, the catheter, tubing or medical line can be taped to thepatient.

Securing a catheter with tape upon the patient traditionally has certaindrawbacks. The use of tape at the insertion site can retain dirt orother contaminant particles, potentially leading to infection of thepatient. Tape also fails to limit catheter motion and, therefore,contributes to motion related complications like phlebitis, infiltrationand catheter migration. Additionally, removal of taped dressings canitself cause undesired motion of the catheter upon the patient.

Taped dressings also require periodic changes. The frequent, oftendaily, removal and reapplication of adhesive tape to the skin of thepatient can excoriate the skin in the area around the dressing. Suchrepeated applications of tape over the catheter or medical line canadditionally lead to the buildup of adhesive residue on the outersurface of the catheter or medical line. This residue can result incontaminants adhering to the catheter itself, increasing the likelihoodof infection of the insertion site. This residue can also make thecatheter or medical line stickier and more difficult to handle forhealthcare providers.

Accordingly, it would be desirable to provide a catheter securementdevice that is simple to use while providing reliable fixation of thecatheter to the patient's skin.

SUMMARY OF THE INVENTION

The present invention relates systems, devices and methods for securinga catheter, tubing, medical line, or other medical device to a patient.

In some embodiments, a securement device for securing a medical devicehaving a suture tab to a patient's body is provided. The device caninclude an adhesive pad having a first surface coated with an adhesiveand a second surface; a tab receiving portion disposed on the secondsurface of the adhesive pad and along a side edge of the adhesive pad;and a downwardly extending post that extends from the top of the tabreceiving portion towards the adhesive pad.

In some embodiments, the downwardly extending post is biased away fromthe side edge. In some embodiments, the downwardly extending post isbiased at an angle between about 0 to 30 degrees from the vertical axis.In some embodiments, the downwardly extending post is configured toengage the suture tab.

In some embodiments, the adhesive pad comprises an opening under the tabreceiving portion that is configured to receive the suture tab.

In some embodiments, the tab receiving portion is transparent.

In some embodiments, the securement device further includes a backinglayer disposed over the adhesive, wherein the backing layer comprises apull tab.

In some embodiments, the backing layer comprises a first portiondisposed proximate the tab receiving portion and having a first pulltab, and a second portion disposed away from the tab receiving portionand having a second pull tab, wherein the first portion and the secondportion are separably removable.

In some embodiments, the adhesive comprises a hydrocolloid adhesive. Insome embodiments, the adhesive further includes an acrylic adhesivedisposed on portions of the adhesive pad configured to be exposed tohigh stress.

In some embodiments, the adhesive pad has skin tone color. In someembodiments, the adhesive pad is transparent. In some embodiments, thetab receiving portion is shaped like a dome.

In some embodiments, the dome has a continuously smooth surface. In someembodiments, the dome has a flattened top portion.

In some embodiments, the tab receiving portion has a height that is lessthan or equal to the height of the medical device.

In some embodiments, a system for securing a medical device having afirst suture tab to a patient's body is provided. The system can includea first engagement tab comprising an adhesive pad having a first surfacecoated with an adhesive and a second surface, a tab receiving portiondisposed on the second surface of the adhesive pad and along a side edgeof the adhesive pad, and a downwardly extending post that extends fromthe top of the tab receiving portion towards the adhesive pad, whereinthe downwardly extending post is disposed through the first suture tab.

In some embodiments, the system further includes an overdressingcovering at least a portion of the first engagement tab and the medicaldevice.

In some embodiments, the system further includes a second engagement tabthat is secured to a second suture tab on the medical device, whereinthe second engagement tab is secured independently of the firstengagement tab.

In some embodiments, the first engagement tab is pivotably engaged withthe first suture tab and the second engagement tab is pivotably engagedwith the second suture tab.

In some embodiments, a system for securing a medical device to apatient's body is provided. The system can include an adaptor having afirst suture tab, wherein the adaptor is removably disposed over aportion of the medical device; and a first engagement tab comprising anadhesive pad having a first surface coated with an adhesive and a secondsurface, a tab receiving portion disposed on the second surface of theadhesive pad and along a side edge of the adhesive pad, and a downwardlyextending post that extends from the top of the tab receiving portiontowards the adhesive pad, wherein the downwardly extending post isdisposed through the first suture tab.

In some embodiments, the system further includes an overdressingcovering at least a portion of the first engagement tab, adaptor and themedical device.

In some embodiments, the system further includes a second engagement tabthat is secured to a second suture tab on the adaptor, wherein thesecond engagement tab is secured independently of the first engagementtab.

In some embodiments, the adaptor comprises a channel for receiving theportion of the medical device. In some embodiments, the channelcomprises a deformable liner. In some embodiments, the deformable lineris elastic and reversibly deformable. In some embodiments, thedeformable liner is made of foam.

In some embodiments, a method of securing a medical device having afirst suture tab to a patient's body is provided. The method can includeproviding a first engagement tab comprising an adhesive pad having afirst surface coated with an adhesive and a second surface, a tabreceiving portion disposed on the second surface of the adhesive pad andalong a side edge of the adhesive pad, and a downwardly extending postthat extends from the top of the tab receiving portion towards theadhesive pad; disposing the downwardly extending post through the firstsuture tab; and adhering the adhesive pad to the patient's body.

In some embodiments, the system further includes disposing anoverdressing over at least a portion of the first engagement tab andmedical device.

In some embodiments, the system further includes providing a secondengagement tab and securing the second engagement tab to a second suturetab on the medical device, wherein the second engagement tab is securedindependently of the first engagement tab.

In some embodiments, the system further includes removing a firstportion of a backing layer disposed over the adhesive, wherein the firstportion of the backing layer covers a portion of the adhesive proximatethe tab receiving portion.

In some embodiments, the system further includes positioning the firstengagement tab on the patient's body after the first portion of thebacking layer is removed.

In some embodiments, the system further includes removing a secondportion of the backing layer after the first engagement tab ispositioned on the patient's body.

In some embodiments, a securement device for securing a medical devicehaving a suture tab to a patient's body is provided. The device caninclude an adhesive pad having a first surface coated with an adhesiveand a second surface; a base disposed on the second surface; an upwardlyextending post that extends from the base and away from the adhesivepad, wherein the post is configured to engage the suture tab; and acover that is slidably attached to the base portion and configured tohave a closed configuration that covers the post and an openconfiguration that exposes the post.

In some embodiments, the cover is reversibly secured to the slot by alocking mechanism.

In some embodiments, the base has a slot and the cover has a rail whichis slidably disposed in the slot.

In some embodiments, the locking mechanism generates a tactile indicatorwhen the cover is moved between the closed configuration and openconfiguration. In some embodiments, the locking mechanism generates anaudible indicator when the cover is moved between the closedconfiguration and open configuration. In some embodiments, the lockingmechanism comprises a rounded protrusion disposed within the slot and acomplementary rounded indentation disposed on the rail. In someembodiments, the locking mechanism comprises a rounded protrusiondisposed on the rail and a complementary rounded indentation disposedwithin the slot.

In some embodiments, the device further includes a backing layerdisposed over the adhesive, wherein the backing layer comprises a pulltab. In some embodiments, the backing layer comprises a first portiondisposed proximate the base and having a first pull tab, and a secondportion disposed away from the base and having a second pull tab,wherein the first portion and the second portion are separablyremovable.

In some embodiments, a system for securing a medical device to apatient's body is provided. The system can include an adaptor having afirst suture tab, wherein the adaptor is removably disposed over aportion of the medical device; and a first securement device comprisingan adhesive pad having a first surface coated with an adhesive and asecond surface, a base disposed on the second surface, an upwardlyextending post that extends from the base and away from the adhesivepad, and a cover that is slidably attached to the base portion andconfigured to have a closed configuration that covers the post and anopen configuration that exposes the post, wherein the post is disposedthrough the first suture tab.

In some embodiments, the system further includes an overdressingcovering at least a portion of the first securement device, adaptor andthe medical device.

In some embodiments, the system further includes a second securernentdevice that is secured to a second suture tab on the adaptor, whereinthe second securement device is secured independently of the firstsecurement device.

In some embodiments, the adaptor comprises a channel for receiving theportion of the medical device. In some embodiments, the channelcomprises a deformable liner. In some embodiments, the deformable lineris elastic and reversibly deformable. In some embodiments, thedeformable liner is made of foam.

In some embodiments, a method of securing a medical device having afirst suture tab to a patient's body is provided. The method can includeproviding a first securement device comprising an adhesive pad having afirst surface coated with an adhesive and a second surface, a basedisposed on the second surface, an upwardly extending post that extendsfrom the base and away from the adhesive pad, and a cover that isslidably attached to the base portion and configured to have a closedconfiguration that covers the post and an open configuration thatexposes the post; disposing the post through the first suture tab;sliding the cover to the closed configuration; and adhering the adhesivepad to the patient's body.

In some embodiments, the method further includes disposing anoverdressing over at least a portion of the first securement device andmedical device.

In some embodiments, the method further includes providing a secondsecurement device and securing the second securement device to a secondsuture tab on the medical device, wherein the second securement deviceis secured independently of the first securement device.

In some embodiments, a securement device for securing a medical deviceto a patient's body is provided. The device can include an adhesive padhaving a first surface coated with an adhesive and a second surface; anda vacuum formed blister pack disposed on the second surface and shapedto conform to a portion of the medical device.

In some embodiments, the vacuum formed blister pack is molded to theportion of the medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a perspective view of one embodiment of a modular cathetersecurement device.

FIG. 2 is a perspective view of another embodiment of a modular cathetersecurement device.

FIG. 3 is a cross-sectional view of an embodiment of an engagement tabof a modular catheter securement device.

FIGS. 4A-5B illustrate other embodiments of the engagement tab.

FIGS. 6-10 illustrate embodiments of various adaptors that providesuture tabs to other medical devices.

FIGS. 11A-11E illustrate the securement of catheters with variousembodiments of the adaptors and engagement tabs.

FIGS. 12A-12E illustrate various embodiments of a securement devicehaving a balloon.

FIGS. 13A-13F illustrate an embodiment of the securement device having abutterfly wrap configuration.

FIGS. 14A-14D illustrate an embodiment of the securement device using agel pad.

FIGS. 15A-15G illustrate various embodiments of securement devices usinga hook and loop fastener.

FIG. 16 illustrates an embodiment of a securement device using snap onposts.

FIG. 17 illustrates an embodiment of a securement device using stakedposts.

FIG. 18 illustrates an embodiment of a quick feed strap slot.

FIG. 19 illustrates an embodiment of a securement device using magnets.

FIG. 20 illustrates another embodiment of a securement device usingdownwardly extending posts.

FIG. 21 illustrates yet another embodiment of a securement device usingdownwardly extending posts.

FIGS. 22A-22C illustrates an embodiment of a securement device usingtear-away pads.

FIGS. 24A and 24B illustrate an embodiment of a securement device havingwire hooks.

FIG. 25 illustrates an embodiment of a securement device made from avacuum formed blister pack.

FIGS. 26A-26D illustrate an embodiment of a securement device formedfrom a wire loop.

FIGS. 27A-27E illustrate an embodiment of a securement device having asheath and hooks.

FIGS. 2SA-28E. illustrate an embodiment of a securement device having asnap-on feature and an expandable anchor.

FIGS. 29A and 29B. illustrate another embodiment of a securement devicehaving an having an expandable anchor.

FIGS. 30A and 30B illustrate yet another embodiment of a securementdevice having an expandable anchor.

FIGS. 31A-31C illustrate art embodiment of a securement device havinganchors configured for subdermal penetration.

FIGS. 32A-32P illustrate an embodiment of a securement device having, aslide-locking feature.

DETAILED DESCRIPTION

FIGS. 1 and 2 illustrate an embodiment of a modular catheter securementsystem and/or device 100 that can be used to secure a catheter 102, tubeor medical line having a catheter hub 104 with suture tabs 106 to apatient's skin. The securement device 100 includes independent andmodular engagement tabs 108 that are configured to engage the suturetabs 106 and thereby secure the catheter hub 106 to the patient's skin.For a typical catheter with two suture tabs 106, the securement device100 includes two engagement tabs 108. In general, the securement device100 has an equal number of engagement tabs 108 as there are suture tabs106. Since the engagement tabs 108 are independent and modular, more orfewer engagement tabs 108 can be used as needed.

The engagement tab 108 has a tab receiving portion 110 that is attachedto an adhesive pad 112. The tab receiving portion 110 can have a cavityand an opening along the side facing the catheter hub 104 and along thebottom of the engagement tab 108 for receiving the suture tab 106. Thetab receiving portion 110 can include a post 114 sized and shaped forengaging and passing through the hole in the suture tab 106. The tabreceiving portion 110 can also have a base portion 111 that can beattached to the adhesive pad 112 and that provides stability to the tabreceiving portion 110. As shown in FIG. 3, the post 114 can be madeintegral with the tab receiving portion 110 and can extend downwardsfrom the top of the tab receiving portion 110 towards the bottom opening116 of the tab receiving portion 110. The post 114 can be biased awayfrom side opening 118 of the tab receiving portion 110, such that thedistal end 120 of the post 114 is biased away from the suture tab 106when the tab receiving portion 110 is engaged with the suture tab 106.The biased post 114 aids in preventing or reducing the likelihood ofaccidental disengagement of the tab receiving portion 110 from thesuture tab 106 when the catheter 102 or catheter hub 104 is pusheddownwards into the patient's skin. As the catheter 102 or catheter hub104 is pushed downwards, the biased post 114 can exert an outwardsand/or upwards force on the suture tab 106 that provides resistance tofurther downwards movement of the catheter 102 or catheter hub 104,thereby preventing and/or resisting accidental disengagement of the tabreceiving portion 110 from the suture tab 106. In some embodiments, thepost 114 can be angled between about 0 to 30 degrees, 0 to 25 degrees, 0to 20 degrees, or 0 to 15 degrees from the vertical axis. In someembodiments, the post 114 is angled at least about 1, 2, 3, 4, 5, 10,15, 20, 25, or 30 degrees from the vertical axis. In some embodiments,the post 114 can be angled less than about 5, 10, 15, 20, 25, or 30degrees from the vertical axis. About or approximately as used hereincan mean within 10%, 20%, or 30%, for example. In some embodiments, thepost 114 can be tapered such that the distal end of the post 114 has asmaller diameter than the proximal portion of the post 114. In someembodiments, the post 114 is not tapered and has a constant diameter. Insome embodiments, the distal end of the post 114 can include a barb,ball, or other retaining mechanism to improve retention of the postwithin the hole of the suture tab.

In some embodiments, the tab receiving portion 110 can be made of aflexible or semi-rigid, material that can bend or flex in response toapplied stress. The added flexibility enables the engagement portion 108to absorb force exerted on the engagement portion 108, thereby reducingthe force exerted on the catheter 102 and/or catheter hub 104 whichreduces the risk of accidental dislodgement of the catheter 102 from thepatient.

In some embodiments, the catheter 102 can include a plurality of lines130 that can be secured to the patient with a line management device140. The line management device 140 can comprise a body portion 142 withone or more channels 144 that can be disposed parallel to one another.The channels 144 are sized and shaped to receive the lines 130. The bodyportion 142 can be disposed on a adhesive pad 146 with features similarto that described herein.

As illustrated in FIG. 4, the adhesive pad 112 can include a peelablebacking layer 122 to cover the adhesive on the adhesive pad 112. Thebacking layer 122 can have a pull tab 124 for removing the backing layer122 from the adhesive pad 112 and thereby exposing the adhesive on theadhesive pad 112. In some embodiments, the backing layer 122 can bedivided into multiple pieces, each with a separate tab 124 to facilitatepeeling. For example, the backing layer 122 can have a first portionthat covers the area around the tab receiving portion 110 and a secondportion away from the tab receiving portion 110. Having two portionsallows only a relatively small portion of the adhesive to be exposedwhile positioning the securement device on the patient, which may alloweasier repositioning of the securement device. In other embodiments, thebacking layer 122 can be formed of a single piece with a single tab 124to facilitate peeling. The backing layer 122 can be removed before theadhesive pad 112 is pressed into contact with the patient's skin. Insome embodiments, the backing layer 122 can be removed prior toinserting the post 114 through the hole in the suture tab 106. In otherembodiments, the backing layer 122 can be removed after inserting thepost 114 through the hole in the suture tab 106.

In some embodiments, the adhesive pads 112 can use a combination of anacrylic adhesive for the high stress points and a hydrocolloid adhesivefor long term securement and comfort. In some embodiments, the adhesivepads 112 can use either the acrylic adhesive or the hydrocolloidadhesive. The backing layer 122 can be made from paper, plastic or anyother suitable material that can be peeled from the adhesive. In someembodiments, a two or more securement devices 100 can be disposed on asingle backing layer 122 that can be perforated or scored between theadhesive pads 122 of the securement devices 100 to allow the securementdevices 100 to be held together during packaging and easy separation ofthe securement devices 100 from each other before use. The adhesive pad112 substrate can be a skin tone fabric or a clear material that allowsfor the skin color to show through in order to minimize the visualimpact of the device on the patient who may have to endure the catheterfor many days. The adhesive pad 112 can be made of a flexible materialso that it can conform to that geometry of the patient's body.

One unique feature of this design is that the securement device 100comes in modular parts, such as the modular engagement tabs 108 that areeach comprised of a tab receiving portion 110 on an adhesive pad 112.The engagement tab 108 is attached to each suture tab 106 on each sideof the catheter hub 104 and adhered to the patient's skin. Because theengagement tabs 108 are separate and modular, the securement device canaccommodate catheter hubs 104 of any width that uses suture tabs 106.This enables a universal fit for many catheter styles or brands.

Attaching the engagement tab 108 to the suture tab 106 on the catheter102 is a simple maneuver that can be accomplished by simply engaging thepost 114 of the engagement tab 108 into the hole of the suture tab 106from the top down. This requires very little manipulation of theindwelling catheter 102 which is a priority of users. Since the modularengagement tabs 108 are independent, each engagement tab 108 can beoptimally positioned sequentially according to the patient anatomy. Thislends flexibility of placement which is another important feature forusers. In addition, in some embodiments, the fit of the post 114 withinthe hole of the suture tab 106 can leave some room for the post 114 topivot within the hole, which can further enhance the ability of themodular securement system to conform to the variable geometry of thepatient's body. This can be accomplished, for example, by making thepost 114 have a smaller diameter than the hole of the suture tab 106.The ability of the engagement tabs 108 to pivot on the suture tab 106allows the engagement tabs 106 and catheter hub 104 or other device toeach lie within different planes if needed, which aids the system inconforming to the patient's body. The adhesive pads 112 of eachengagement tab 108 can be trimmed to any shape if needed. Once bothengagement tabs 108 are in place, the catheter 102 is held extremelywell by the adhesive pads 112. The shape and placement of adhesiveprovides resistance to lateral and upwards pulling of the catheter 102or tubing, thereby ensuring proper securement of the catheter 102 to thepatient.

In some embodiments, the engagement tab 108 can be dome shaped withcurved surfaces, as illustrated in FIGS. 1 and 2. The dome in FIG. 2 hasa continuously smooth surface while the dome in FIG. 1 has a noncontinuous smooth surface with a flattened top portion. In someembodiments, a dome with a continuously smooth surface can be moreeasily covered with an overdressing such that pockets of air trappedbetween the overdressing and dome are reduced. The engagement tab 108can be made of a transparent material, such as a transparent plastic,that allows the user to visualize the post 114 through the walls of thedome forming the tab receiving portion 110. The post 114 can be madeopaque so that it is easier to visualize. For example, the post can becoated or made from an opaque material. The discrete shape and size ofthe dome permits full visualization of the catheter hub and skin entrypoint. The engagement tab 108 can have a low profile which enablessmooth placement of overdressings, such as Tegaderm™, over the catheter102, catheter hub 104, and/or securement devices 100. For example, theengagement tab 108 can have a height that is less than or equal to theheight of the catheter 102 and/or the catheter hub 104. This results ina securement device 100 with optional overdressing that is no higherthan the catheter 102 or catheter hub 104 itself with no obtrusivebumps, housings, catch points and the like for maximum patient comfortwhile reducing the likelihood of accidentally snagging and dislodging orremoving the catheter 102, catheter hub 104 and/or securement device100.

In some embodiments, as illustrated in FIGS. 4A-4C, the engagement tab108 can have an alternative tab receiving portion 111. Rather than adome shaped tab receiving portion 110 as shown in FIGS. 1-3, theengagement tab 108 can have a tab receiving portion 111 formed from anangled strip of material with a post 114 extending downwards from thedistal end of the strip. As above, the post 114 can be biased inwardsand away from the distal end of the strip. The strip can be straight orcurved. In curved embodiments, the curve can be convex, concave, or acombination of convex and concave curves. As above, the strip-likeengagement tab 108 can be flexible or semi-rigid, which enables toengagement tab 108 absorb force exerted on the engagement tab 108, whichreduces the force exerted on the catheter 102 and/or catheter hub 104.One difference between the strip-like engagement tab and the dome-likeengagement tab is that the post 114 is shielded by the dome andaccessible in the strip embodiment. In some embodiments, it can beeasier to manipulate the post 114 without detaching the adhesive pad 112from the skin in the strip embodiment in the event that the post 114becomes dislodged and needs to be repositioned through the suture tab106. In some embodiments, a dome or enclosure can be placed over thestrip-like engagement tab 108 to form a hybrid embodiment.

An alternative embodiment of the engagement tab is illustrated in FIGS.5A and 5B. The engagement tab 110B is can be form an enclosure like thedome embodiment, except that the shape of the enclosure can berectangular or square. The engagement tab 110B can have the otherfeatures described for the dome embodiment, such as having a biased post114 and be made from a transparent material. In some embodiments, theenclosure can be partially rectangular or square and partially curved.

In some embodiments, the catheter and/or catheter hub may not havesuture tabs to which the securement device can be attached. In thissituation, adaptors can be used to provide suture tabs to the catheter.Various adaptors can be used to fit over catheters, luer connectors,standard catheter hubs, custom catheter hubs, and other catheter relatedparts near the insertion point. The combination of the modularsecurement device with an adapator allows the securement device to beused in a large variety of catheters

For example, FIG. 6 illustrates one embodiment of an adaptor 200 thatcan be fastened to a luer connector, catheter, or other generallytubular catheter related part. The adaptor 200 can have an adaptor body202 and a channel 204 disposed through or within the adaptor body 202for receiving the luer connector, catheter, or other generally tubularcatheter related part. The adaptor body 202 can have or rest on a base206 that is configured to be placed on the patient's skin. The base 206can include suture tabs 208 that extend transversely away from thechannel 204 to which engagement tabs 108 can be fastened to as describedabove.

In some embodiments, the channel 204 or the longitudinal axis of thechannel 204 can be angled downwards with respect to the base 206 orplane defining the base 206. For example, the channel 204 can be angleddownwards between about 0 to 5, 0 to 10, 0 to 15, 0 to 20, 0 to 25, 0 to30 degrees, 0 to 35, 0 to 40, or 0 to 45 degrees with respect to thebase. The angled channel 204 allows the distal end of the catheter to bepointed towards the skin, thereby allowing the user to more easilycontrol the angle of insertion of a needle or the catheter into thepatient's body. Control of the angle of insertion along with thedistance of insertion is important in preventing or reducing the forcesthat the indwelling device exerts on the patient's tissue, which canhelp reduce damage to the tissue.

In some embodiments, the base 206 can have an access slot 210 thatprovides access to the channel 204. The access slot 210 can run parallelto the channel 204. In some embodiments, the access slot 210 can have awidth that is less than the diameter of the channel 204, which allowsthe channel 204 to securely retain the inserted device without thedevice inadvertently falling out. In some embodiments, the access slot210 tapers such that the width of the access slot 210 adjacent to thechannel 204 is narrower than the diameter of the channel 204, while thediameter of the access slot 210 gradually increases in width as it movesaway from the channel 204, as illustrated in FIG. 8, for example. Insome embodiments, the adaptor body 202 can have a plurality of alignmentslots 212 that are oriented transversely to the axis of the channel 204.These alignment slots 212 can function as alignment features byrestraining a tab on the luer connector, catheter, or other generallytubular catheter related part, to restrain the axial movement of thecatheter within the adaptor 200. In some embodiments, the adaptor body204 does not have alignment slots 212.

In some embodiments, the channel 204 can be coated or covered with aliner that can provide a gripping surface to secure the inserted device.The liner can be soft, elastic, spongy, resilient and/or reversiblydeformable to conform to the inserted device and to allow the adaptor200 to secure a wider variety of inserted devices. In some embodiments,the liner can be made of a foam or sponge material. In some embodiments,the liner can be expandable and filled with a liquid, gel and/or a gas.The liner can be included in any of the adaptor embodiments describedherein.

FIG. 7 illustrates another embodiment of an adaptor 220 having anadaptor body 222 that encloses a channel 224. The base 226 can beintegral with the adaptor body 222. Suture tabs 228 can be provided thatextend from the base 226, and to which engagement tabs 108 can besecured. In some embodiments, including other embodiments describedherein, the suture tabs 228 can be offset from the base 226. In theillustrated embodiment, the adaptor body 222 can be made of two sections230, 231 that together define the channel 224 and can be connecttogether by a hinge 232 that allows the two sections 230, 231 to beseparated, thereby exposing the channel 224 and allowing a device to beinserted into the channel 224. A locking mechanism 234, such as a latchfor example, can be used to reversibly secure the two sections 230, 231together. As described above, the channel 224 can be angled with respectto the base 226. An alignment feature 236 on the top surface of theadaptor body 222 can indicate to the user which direction in which toinsert the device into the channel. The alignment feature 236 can alsobe included in the other adaptor embodiments described herein.

FIG. 8 illustrates another embodiment of an adaptor 240. The adaptor 240has an adaptor body 242 that defines a channel 244 for receiving aninserted device as described herein. As described herein, the channel244 can be angled with respect to the base 246. The body 242 can have abase 246 and suture tabs 248 that are offset from the base 246. Theoffset can be between about 0 to 2, 0 to 4, 0 to 6, 0 to 8, or 0 to 10mm. An access slot 250 can be provided on the bottom of the adaptor body242 to provide access to the channel 244. As described above, the accessslot 250 can have a taper such that it is narrower than the diameter ofthe channel 244 at a point adjacent to the channel 244, butprogressively widens as the access slot 250 moves away from the channel244. This configuration provides a larger target zone for insertion ofthe inserted device into the channel 244, and also acts to funnel theinserted device to the channel 244, thereby facilitating insertion ofthe inserted device into the channel 244. The channel 244 can have aliner 252 for gripping the inserted device, as further described hereinin other embodiments. For example, the liner 252 can be soft, elastic,and/or deformable, which allows the liner 252 to conform to inserteddevices of a variety of shapes and sizes.

FIG. 9 illustrates another embodiment of an adaptor 260 that can be usedto provide suture tabs to a catheter, luer adapter, and the like. Theadaptor 260 can include an adaptor body 262 that encircles or partiallyencircles a channel 264. The adaptor body 262 can have a base 266, whichcan be integral to the adaptor body 262. The suture tabs 268 can extendfrom the base 266 and also be integral to the base 266. A slot 270 canbe formed in the base 266 to provide access to the channel 264 and todivide the base 266 into two separable parts. The body 262 can be madeof a flexible material, such as rubber or another flexible elastomericpolymer, such that the slot 270 can be widened by deforming the body262. For example, force can be applied downwards on the top portion ofthe body 262 while an upwards force can be applied to the suture tabs268 in order to widen the slot 270 so that the adaptor 260 can be placedover the inserted device. In some embodiments, the slot 270 can benarrow or closed in the unstressed configuration such that the channel264 substantially encloses an entire circumference. In otherembodiments, the slot 270 can be wider, such as in the embodimentsdisclosed above, so that the channel 264 is configured to encircle onlya portion of the inserted device, which is typically at least 50% of thecircumference of the inserted device. As above, the channel 264 can beangled with respect to the base, and the channel 264 can include aliner.

FIG. 10 illustrates another embodiment of an adaptor 280 that can beused to secure a specialty catheter or hub, such as neural blockcatheter, for example. The adaptor 280 can include a adaptor body 282having a first portion 284, a second portion 286 and a third portion 288disposed between the first portion 284 and the second portion 286. Thefirst portion 284 can include an open channel 290 formed at the top ofthe first portion 284, such that the inserted device can be insertedinto the channel 290 from above by pushing the inserted device downwardsinto the channel 290. The second portion 286 also includes a second openchannel 292 formed at the top of the second portion 286. The secondchannel 292 may have the same or may have a different cross-sectionalprofile than the first channel 290. In some embodiments, both the firstchannel 290 and the second channel 292 have arcuate, semi-circularcross-sectional profiles. In some embodiments, the length of the firstchannel 290 is greater than the length of the second channel 292. Insome embodiments, the length of the first channel 290 is the same as orgreater than the length of the second channel 292. The third portion 288can be a flat depression with a surface that lies below the lowest pointof the first channel 290 and the second channel 292. In someembodiments, the suture tabs 294 can extend outwards from the firstportion 286 and can be offset from the base 296 of the adaptor body 282.As described above, the first channel 290 and/or the second channel 292can be angled with respect to the base, and a liner can be added toeither channel.

FIGS. 11A-11E illustrate the attachment of the adaptors described hereinto luer adaptors or specialty hubs. For example, FIGS. 11A and 11Billustrate the attachment of the adaptor 200 described in FIG. 6 with aluer adaptor and the attachment of engagement tabs 108 to the suturetabs 208 provided by the adaptor 200, thereby securing the catheter inplace. In practice, the adaptor 200 can first be placed over the lueradaptor 300 by, for example, snapping the luer adaptor 300 through theaccess slot 210 and into the channel 204 in order to provide suture tabs208 to the luer adaptor 300. A securement device 100 can then beattached to the suture tabs 208 as described above. A line managementdevice 302 can be used to secure the lines of the catheter.

FIG. 11C illustrates the attachment of the adaptor 220 described in FIG.7 to a luer adaptor 300. As described above, the adaptor 220 can beopened into two pieces and then locked over the luer adaptor 300 toprovide suture tabs 228 to the luer adaptor. A securement device 100 canthen be attached to the suture tabs 228 as described above. A linemanagement device 302 can also be used to secure the lines of thecatheter.

Similarly, FIGS. 11D-11E illustrate the attachment of the adaptorsdescribed in FIGS. 8-10 to either a luer adaptor 300 or a specialty hub310 to provide suture tabs to the luer adaptor 300 or specialty hub 310.One the suture tabs are provided, a securement device 100 can beattached to the suture tabs as described above. A line management device302 can also be used to secure the lines of the catheter. In someembodiments, the line management device 302 can be attached to topportion of the adhesive pad 112.

Alternative Securement Devices

FIGS. 12A-12E illustrate another embodiment of a securement device 1200.The securement device 1200 includes an adhesive pad 1202 and aninflatable tube 1204 disposed on or integral to the adhesive pad 1202.The inflatable tube 1204 can have an inflation port 1206 that can beused to inflate the inflatable tube 1204 with a gas or liquid. In someembodiments as illustrated in FIGS. 12D and 12E, the inflatable tube1204 further includes a longitudinal split 1208 that allows theinflatable tube 1204 to partially unfurl, which can make insertion orremoval of the catheter 1210 through the inflatable tube 1204 easier. Tosecure the catheter 1210, the catheter 1210 can be inserted through theinflatable tube 1204 and then the inflatable tube 1204 can be inflatedto compress the catheter 1210 within the inflatable tube 1204. As theinflatable tube 1204 is inflated, the diameter of the inflatable tube1204 decreases until contact is made with the catheter 1210.

FIGS. 13A-13F illustrate another embodiment of a securement device 1300.The securement device 1300 includes an adhesive pad 1302 and an adhesivewrap 1304 that is attached to the adhesive pad 1302. The adhesives onthe adhesive pad 1302 and the adhesive wrap 1304 can be disposed on thenonadjacent surfaces of each so that the adhesive pad 1302 can beattached to the patient's skin and the adhesive wrap 1304 can be wrappedover a catheter 1306 or other device placed on top of the adhesive wrap1304. The adhesive wrap 1304 can be flexible so that it can be easilywrapped over and around the catheter 1306. The adhesive wrap 1304 can beeither permanently or reversibly attached to the adhesive pad 1302.Reversible attachment can be accomplished by using adhesives, hook andloop fasteners, latches, clips and the like. Generally, the middleportion 1308 of the adhesive wrap 1304 is attached to the adhesive pad1302 such that the adhesive wrap 1304 has two wings 1310 than can beused to wrap around the catheter. Both the adhesive wrap 1304 and theadhesive pad 1302 can be covered by one or more backing layers which canbe peeled off to expose the adhesive.

FIGS. 14A-14D illustrate another embodiment of a securement device 1400.The securement device 1400 includes an adhesive pad 1402 and a gel pad1404 disposed on the adhesive pad 1402. An adhesive film 1406 can bedisposed over the gel pad 1404 to secure a catheter 1408 or other devicethat has been placed on the gel pad 1404. The gel pad 1404 can providecompression around the catheter 1408 and can further be coated orimpregnated with an antimicrobial agent. The adhesive film 1406 can betransparent and can be removably adhered over the gel pad 1404 andcatheter 1408.

FIGS. 15A-15G illustrate additional embodiments of securement devicesinvolving a hook and loop fastener. For example, FIG. 15A illustrates asecurement device 1500 having an adhesive pad 1502 with an adhesive onone side to bind to skin and loops 1508 or hooks on the other side. Aflexible covering 1504 has hooks 1510 or loops complementary to theadhesive pad 1502 disposed on one side of the flexible covering 1504. Amolded cover 1506 can optionally be used to cover the catheter orcatheter hub or other device that is placed on the adhesive pad 1502.The molded cover 1506 can be shaped and sized to conform to thecatheter, catheter hub or other device. After the device is placed onthe adhesive pad 1502, the flexible covering 1504 is fastened to theadhesive pad 1502 over the device using the hook and loop fastener. FIG.15G illustrates another embodiment of a securement device that issimilar to the embodiment described in FIG. 15A. The difference is thatthe molded cover 1506 shown in FIG. 15A is replaced with a base 1590have two posts 1592 that can engage the holes in the suture tabs of acatheter hub.

FIG. 15B illustrates another embodiment of a securement device 1520. Thesecurement device 1520 can have an adhesive pad 1522 and a base 1524disposed on the adhesive pad 1522. The base 1524 can optionally haveposts 1526 sized and spaced to fit through the suture tabs on a catheterhub. One side of the base 1526 can have a slot 1528 for receiving astrap 1530 that is attached to the other side of the base 1526. Aportion of one side of the strap 1530 can be covered in hooks 1532 andanother portion of the same side of the strap can be covered in loops1534. To secure the catheter hub, the suture holes of the catheter hubare disposed over the posts 1526, if present, and the strap 1530 ispassed over the catheter hub and through the slot 1528. The strap 1530is then tightened and can be looped back on itself such that the hooksand loops on the strap 1530 are engaged to secure the strap 1530.

FIGS. 15C and 15D illustrate a molded capture cover 1540 with strapslots 1542 and a catheter hub 1560 with molded in strap slots 1562,respectively, that can be used with the adhesive pads illustrated inFIGS. 15E and 15F. FIG. 15E illustrates an adhesive pad 1550 having twoattached straps 1552. The straps 1552 can be spaced apart to match theseparation of the strap slots in the molded capture cover or catheterhub. One side of each strap 1552 can be covered with a loop 1554 or hookmaterial while an area of the adhesive pad 1550 adjacent or proximatethe strap 1552 is covered with a complementary hook 1556 or loopmaterial to secure the strap 1552. The straps 1552 are designed to befolded outwards towards the ends of the adhesive pad 1550. FIG. 15Fillustrates a two piece embodiment of the adhesive pad illustrated inFIG. 15E where the middle portion between the straps has been removed toform two adhesive pads 1550, each with a single strap 1552 located onone edge of the adhesive pad 1550. To secure the molded capture cover1540 or catheter hub 1560 to the adhesive pad 1550, the strap 1552 ispassed through the strap slot 1542, 1562 and then looped back on itselfso that the hook and loop material engage each other. The two pieceadhesive pads 1550 can be used with a wide variety of molded capturecovers and molded catheter hubs of different sizes as long as each havestrap slots.

FIG. 16 illustrates a securement device 1600 having an adhesive pad1602, a base 1604 disposed on the adhesive pad 1602. The base 1604 canhave a pair of snap-on posts 1606 that can snap into the holes on thesuture tabs 1608 of a catheter hub 1610. The snap-on posts 1606 can bemade by cutting a post in half and then separating the two halves by asmall distance such that gap is formed between the two halve. The posts1606 can have tapered end portions that are wider than the post stem,such that insertion of the posts 1606 into the holes forces the twohalves of each post 1606 together until the tapered end portions passthrough the hole, after which the post halves can once again separate.The width or diameter of the two tapered end portion halves whenseparated can be slightly larger than the hole diameter, and the widthor diameter of the two tapered end portion halves when pushed togethercan be smaller than the hole diameter. This allows the tapered endportion to pass through the hole while providing a restraining effectafter passing through the hole.

FIG. 17 illustrates an embodiment of a post 1700 having a hole 1702oriented transversely to the post axis. The hole 1702 can be locatedproximate the free end of the post 1700. A pin 1704 or stake can beinserted through the hole 1702 in order to secure a suture tab that hasbeen placed over the post 1700. The pins 1704 can be connected togetheror can be independent.

FIG. 18 illustrates an embodiment of a quick feed strap slot 1800. Thequick feed strap slot 1800 has an opening 1802 that is narrower than theslot 1800 and in communication with the slot 1800 that provides accessto the slot 1800 from the side of the hub 1804 or device. A strap 1806can be pinched together to narrow the width of the strap 1806, which canbe then passed through the opening 1802 and into the slot 1800.

FIG. 19 illustrates an embodiment of a securement device 1900 that usesa base 1902 with one or more magnets 1904 to secure a molded cover 1906or molded hub with complementary magnets 1908. The attractive forcebetween the complementary magnets located on the base and the moldedcover secures the parts together.

FIG. 20 illustrates another embodiment of a securement device 2000 thathas an adhesive pad 2002 and slot retainer 2004 disposed on the adhesivepad 2002. The slot retainer 2004 can have a housing 2006 with a slot2008 located on the top of the housing 2006. The slot retainer 2004 andtwo openings 2010, 2012 to pass the catheter 2020 and lines 2022. Thehousing 2006 can also have downward extending posts 2014 for engagingthe holes 2024 suture tabs of the catheter hub 2026. The housing 2006 isdesigned to be placed over the catheter hub 2026 with the posts 2014engaging the holes in the suture tabs. In some embodiments, a portion ofthe hub can extend through the slot 2008 in the housing 2006.

FIG. 21 illustrates another embodiment of a securement device 2100 witha molded cover 2102 having a pair of downwardly extending posts 2104 andtwo flexible wings 2106. If the wings 2106 are coated with an adhesive,the wings 2106 can be directly adhered to the patient's skin. If thewings 2106 are covered with a hook and loop fastener material, the wings2106 can be fastened to an adhesive pad with complementary hook and loopfastener material. The posts 2104 can be inserted into the holes ofsuture tabs.

FIGS. 22A-22C illustrate another embodiment of a securement device 2200having an adhesive pad 2202 with tear-away side portions 2204. Thebottom surface of the adhesive pad 3202 can be coated with an adhesive.The central portion 2206 of the adhesive pad 2202 can also have anadhesive coating the top surface. The central portion 2206 can be sizedand shaped to match a catheter hub 2208 or other device such that thecatheter hub can be adhered to the central portion 2206. The sideportions 2204 can be optionally tom away from the central portion 2206.The boundary line between the side portions 2204 and the central portion2206 can be perforated or scored to facilitate separation of the sideportions 2204.

FIG. 23 illustrates another embodiment of a securement device 2300having an adhesive. pad 2302 and a nested hub 2304 secured to theadhesive pad 2302. The nested hub 2304 can have a receiving portion 2306shaped to receive a catheter hub. The receiving portion 2306 can alsohave suture tab receiving portions 2308 for receiving the suture tabs onthe catheter hub. The suture tab receiving portion 2308 can have a post2310 for securing the suture tabs. The nested hub 2304 can have a strap2312 attached to one side of the nested hub 2304 and a buckle slot 2314located on the other side of the nested but 2304. The strap 2312 can beused to secure a catheter hub placed in the nested hub 2304. To securethe catheter hub, the strap 2313 can be passed through the buckle slot2314, tightened, and then fastened to itself using a fastener such ashook and loop fasteners.

FIGS, 24A and 2413 illustrate another embodiment of a securement device2400. The securement device 2400 is formed from an adhesive pad 2402that has an embedded hook 2404 that can pass through the hole in thesuture tab and lock the suture tab in place. The book 2404 can be madeof a metal or plastic wire. The hook 2404 can be rotationally orpivotably attached to the adhesive pad 2402 and can be biased to aclosed position. The hook 2404 can have an axle portion 2406 that can berotatably attached to the adhesive pad 2402. For example, the axleportion 2406 can be threaded through the adhesive pad 2402 or can bedisposed in a channel in the adhesive pad 2402. The channel can beformed by molding or by folding a portion of the adhesive pad overitself. The bias can be applied by a spring attached to the hook 2404.To pass the hook 2404 through the suture tab, the hook 2404 can berotated so that it faces upwards and can be threaded through the hole inthe suture tab. When the hook 2404 is released, the hook's 2404 naturalbias to the closed position can automatically rotate the hook 2404 backto the closed position, thereby securing the suture tab. For securing acatheter hub having two suture tabs, two securement devices 2400 can beused as shown in FIG. 24B to secure the catheter hub to the patient.

FIG. 25 illustrates another embodiment of a securement device 2500. Thesecurement device 2500 includes a vacuum formed blister pack 2502 thatcan be formed to match the size and shape of any catheter hub or otherportion of a catheter or medical device by using the catheter hub,catheter or medical device as a mold for the blister pack. The blisterpack 2502 can have a base 2504 with an adhesive that allows the base2504 to function as an adhesive pad. The base 2504 can be adhereddirectly to the patient's skin or adhered to an adhesive pad or overlay2506 with an integrated tube or line management structure 2508. In someembodiments, the blister pack 2502 can be integrated into the adhesivepad with the line management structure.

FIGS. 26A-26D illustrate another embodiment of a securement device 2600.The securement device 2600 is formed from a coiled wire with a pluralityof spiral loops 2602 and a penetrating tip 2604. The securement device2600 can also have a handle 2606 to facilitate rotation of thesecurement device 2600 over the catheter. The securement device 2600 isplaced over a catheter such that the catheter is disposed through theloops 2602 of the wire. Rotating the coils drives the penetrating tip2604 in a corkscrewing action into the patient's skin, thereby securingthe catheter to the patient's skin. The catheter can have grooves forguiding and holding the loops of the wire coil in place on the catheter.The coils can grip the catheter sufficiently to secure the catheter onthe patient. In some embodiments, the diameter of the loops in anunstressed state is smaller than the diameter of the catheter in orderfor the loops to provide sufficient force against the catheter.

FIGS. 27A-27E illustrate another embodiment of a securement device 2700.The securement device 2700 is a catheter anchor formed by an anchorportion 2702 having one or more hooks 2704 extending from a collarportion 2706. For example, the anchor portion 2702 can have two hooks,three hooks, four hooks, or greater than four hooks. The collar portion2706 fits over the catheter and can be secured or fastened to thecatheter. In some embodiments, the collar portion 2706 can be snappedover the catheter. An anchor sheath 2708 can be disposed over the anchorportion 2702 to cover the hooks 2704 during catheter insertion. Thehooks 2704 can be elastic or superelastic such that the hooks can bestraightened out by the sheath in a covered low profile configuration.To deploy the hooks 2704, the sheath 2708 can be retracted from theanchor portion 2702 to expose the hooks 2704, which bend elasticallyback towards its deployed configuration with the tips of the hooksextending outwards and into the tissue, thereby anchoring the catheter.In some embodiments, the catheter securement device 2700 can be advancedover the catheter and partially into the patient's skin before thesheath 2708 is retracted to expose the hooks 2704. The remove thecatheter, the sheath 2708 can be advanced back over the hooks 2704 tocompress the hooks against the catheter, thereby allowing the catheterto be removed.

FIGS. 28A-28E illustrate another embodiment of a securement device 2800.The securement device 2800 can be made from a snap on sheath 2802 ortube that can snap onto a catheter to provide anchoring. The sheath 2802can have a slit 2804 or gap that allows the sheath 2802 to be snappedonto the catheter. The securement device 2800 can have a radiallyexpandable anchor portion 2806 that has a deployed configuration and anon-deployed configuration, where the anchor portion 2806 has a lowprofile in the non-deployed configuration, as shown in FIG. 28B, such asbeing in line with the rest of the sheath 2802. In the deployedconfiguration, the anchor portion 2806 can have a radially expandedprofile with an increased diameter relative to the non-deployedconfiguration, as illustrated in FIG. 28C. In some embodiments, theanchor portion 2806 can be deployed by actuating the proximal portion2808 of the sheath 2802, for example by retracting the proximal portion2808, which retracts the distal portion 2810 of the sheath 2802 andcompresses the anchor portion 2806. As the anchor portion 2806 isaxially compressed, it expands radially outwards, thereby anchoring thecatheter in the tissue. In some embodiments, the anchor portion 2806 canbe deployed within the epidermis or dermis layer of the skin, or betweenthe epidermis and dermis, or below the epidermis or dermis, such assubcutaneous deployment for example. In some embodiments, the anchorportion 2806 can be deployed within other tissues or cavities or lumenswithin the body. In some embodiments, the anchor portions 2806 can bestowed after deployment by, for example, advancing the proximal portion2808 to advance the distal portion 2810 of the sheath 2802 anddecompress the anchor portion 2806. As the anchor portion 2806 isaxially decompressed, it retracts radially inwards until it no longerprotrudes from the catheter or is flush with the catheter.

In some embodiments, as illustrated in FIG. 28D, the proximal portion2808 can be provided with grip wing 2812 or other gripping features thatfacilitate the gripping, actuating, retracting and/or advancing of theproximal portion 2808 to deploy or stow the anchor portion 2806. In someembodiments, as illustrated in FIG. 28E, the sheath 2802 can have ainflation port 2814 that is in fluid communication of the anchor portion2806 and that allows the anchor portion 2806 to be inflated and deflatedto radially expand and retract the anchor portion 2806. The anchorportion 2806 can be inflatable such as a balloon, for example.

FIGS. 29A and 29B illustrate another embodiment of a securement device2900 with an expanding anchor portion 2906 that is similar to theexpanding anchor portion described above in FIGS. 28A-C. In someembodiments as illustrated in FIGS. 29A and 29B, the securement device2900 can have a sheath 2902 that completely encircles the catheter 2902and can be integrated with the catheter. In some embodiments, the sheath2902 can have a longitudinal slit as described above to allow thesecurement device 2900 to be removably attached to the catheter. Thesheath 2902 can have a radially expandable anchor portion 2906 that canbe made of a mesh or woven material. In other embodiments, the anchorportion 2906 can be made of a membrane or sheet. As described above, theproximal portion 2908 of the sheath 2902 can be actuated, for exampleretracted proximally, which causes the distal portion 2910 of the sheath2902 to also retract proximally to collapse and radially expand theanchor portion 2906. Also as described above, the proximal portion 2908can be advanced distally to decompress the anchor portion 2906 torestore the anchor portion 2906 to its non-deployed state. The proximalportion 2908 can have a gripping portion 2912 that extends radiallyoutwards and facilitates the gripping, actuating, retracting and/oradvancing of the proximal portion 2908 to deploy or stow the anchorportion 2906.

FIGS. 30A and 30B illustrate another embodiment of the securement device3000 with two expandable anchor portions, a distal expandable anchorportion 3006 and a proximal expandable anchor portion 3007. The twoanchor portions can be disposed on a sheath 3002 as described above andcan be actuated in a similar manner to deploy the anchor portions.Providing a second anchor portion allows the anchor portions to sandwichthe skin or other tissue layer between the anchors, thereby reducing thein and out movement of the catheter in the tissue. For example, thedistal anchor portion 3006 can be deployed subcutaneously and theproximal anchor portion can be deployed 3007 against the outside surfaceof the skin. In some embodiments, the two anchors can be simultaneouslydeployed by a single actuation of the sheath, while in otherembodiments, the two anchors can be independently deployed.

FIGS. 31A-31C illustrate another embodiment of a securement device 3100that can be reversibly attached to a catheter. The securement device3100 can have a base 3102 and a cover 3104. The base 3102 and cover 3104can be attached together via a hinge 3105 or other mechanism that allowsthe cover 3104 to pivot with respect to the base 3102. The base 3102 andthe cover 3104 can have a channel 3106 that is configured to receive thecatheter and in conjunction with the base and cover forms a cathetershaft clamp area. The channel 3106 can have an opening in the proximalend of the base and cover assembly and an opening in the bottom portionof the base 3102 that allows the catheter to pass through the base andcover assembly and into the patient's skin. The cover 3104 can have oneor more, for example two, anchor tangs 3108 that can be elongate andarcuate and have tissue penetrating tips. The base 3102 can havepenetration guide channels 3110 that receive the anchor tangs 3108 andhelp guide and angle the anchor tangs 3108 into the skin. In someembodiments, the anchor tangs 3108 are configured to achieve subdermalor subcutaneous penetration. In some embodiments, the anchor tangsextend from the bottom surface of the cover 3104 such that cover is inthe fully opened configuration, the tissue penetrating tips of theanchor tangs are disposed within the penetration guide channels 3110.The anchor tangs 3108 can be deployed to penetrate the patient's skin byclosing the cover 3104 which drives the anchor tangs 3108 into thepatient's skin. The anchor tangs 3108 can be driven into the skin at anangle such that the tissue penetrating tips are directed proximally. Theguide channels 3110 can be oriented to slant proximally to facilitateentry of the anchor tangs 3108. When fully deployed, the anchor tangs3108 can be positioned substantially longitudinally within or under theskin relative to the skin layer. In addition, the guide channels 3110are located around or proximate the opening on the base 3102 where thecatheter enters the skin. The location and orientation of the guidechannels 3110 along with the shape and orientation of the anchor tangs3108 allow the anchor tangs to enter the skin at the same location asthe catheter entry so that no new entry site is created. Instead, theanchor tangs 3108 can enter alongside the catheter shaft. The cover 3104can be secured to the base using a latching mechanism 3112 or otherlocking or fastening mechanism.

FIGS. 32A-32P illustrate another embodiment of a securement device 3200.The securement device 3200 can be modular such that the securementdevice 3200 can be independently attached to each suture tab on acatheter hub. The structure and use of the securement device 3200 issimilar in some respects to the embodiments described above with respectto FIGS. 1-3, for example. As shown in FIGS. 32A and 32B, the securementdevice 3200 can include independent and modular engagement tabs 3202that are configured to engage the suture tabs and thereby secure thecatheter hub to the patient's skin. For a typical catheter with twosuture tabs, the securement device 3200 includes two engagement tabs3202. In general, the securement device 3200 has an equal number ofengagement tabs 3202 as there are suture tabs. Since the engagement tabs3202 are independent and modular, more or fewer engagement tabs 3202 canbe used as needed.

The engagement tab 3202 can have a base 3204 that is attached to anadhesive pad 3206. The base can have a post 3208 sized and shaped forengaging and passing through the hole in the suture tab. The post 3208can extend upwards from the base 3204. In some embodiments, the post3208 can be biased away from the side of the base 3204 that faces thecatheter hub, such that the distal end of the post 3208 is biased awayfrom the suture tab when the base 3204 and post 3208 are engaged withthe suture tab. The biased post 3208 aids in preventing or reducing thelikelihood of accidental disengagement of the engagement tab 3202 fromthe suture tab when the catheter or catheter hub is pulled upwards awayfrom the patient's skin. As the catheter or catheter hub is pulledupwards, the biased post 3208 can exert an outwards and/or downwardsforce on the suture tab that provides resistance to further upwardsmovement of the catheter or catheter hub, thereby preventing and/orresisting accidental disengagement of the engagement tab 3202 from thesuture tab. In some embodiments, the post 3208 can be angled betweenabout 0 to 30 degrees, 0 to 25 degrees, 0 to 20 degrees, or 0 to 15degrees from the vertical axis. In some embodiments, the post 3208 isangled at least about 1 , 2, 3, 4, 5, 10, 15, 20, 25, or 30 degrees fromthe vertical axis. In some embodiments, the post 3208 can be angled lessthan about 5, 10, 15, 20, 25, or 30 degrees from the vertical axis.About or approximately as used herein can mean within 10%, 20%, or 30%,for example. In some embodiments, the post 3208 can be tapered such thatthe distal end of the post 3208 has a smaller diameter than the proximalportion of the post 3208. In some embodiments, the post 3208 is nottapered and has a constant diameter. In some embodiments, the distal endof the post 3208 can include a barb, ball, or other retaining mechanismto improve retention of the post within the hole of the suture tab.

The engagement tab 3202 can further include a slidable cover 3210 thatfits over and covers the base 3202 and the post 3208. The cover 3210 canbe retracted away from the catheter hub to expose the post 3208 in anopen configuration and can be advanced towards the catheter hub to coverthe post 3208 in a closed configuration. The cover 3210 can be slidablymounted to the base 3202 by using, for example, a groove and railconnection between the two. For example, the cover 3210 can have tworails 3212 that fit into corresponding grooves 3214 located on the base3202 and allow the cover to slide back and forth over the base 3202. Thecover 3210 can have grip portions 3218 that protrude outwards from thecover 3210 in a direction transverse to the sliding motion of the cover3210. The grip portions 3218 facilitate gripping and manipulation of thecover 3210 by the operator.

In some embodiments, the engagement tab 3202 can be made of a flexibleor semi-rigid material that can bend or flex in response to appliedstress. The added flexibility enables the engagement tab 3202 to absorbforce exerted on the engagement tab 3202, thereby reducing the forceexerted on the catheter and/or catheter hub which reduces the risk ofaccidental dislodgement of the catheter from the patient.

As illustrated in FIGS. 32C and 32D, the adhesive pad 3206 can include apeelable backing layer 3216 to cover the adhesive on the adhesive pad3206. The backing layer 3216 can have a pull tab for removing thebacking layer from the adhesive pad 3206 and thereby exposing theadhesive on the adhesive pad 3206. In some embodiments, the backinglayer 3216 can be divided into multiple pieces, each with a separate tabto facilitate peeling. For example, the backing layer 3216 can have afirst portion that covers the area around the base 3202 and a secondportion away from base 3202. Having two portions allows only arelatively small portion of the adhesive to be exposed while positioningthe securement device 3200 on the patient, which may allow easierrepositioning of the securement device. In other embodiments, thebacking layer 3216 can be formed of a single piece with a single tab tofacilitate peeling. The backing layer 3216 can be removed before theadhesive pad 3206 is pressed into contact with the patient's skin. Insome embodiments, the backing layer 3216 can be removed prior toinserting the post through the hole in the suture tab. In otherembodiments, the backing layer 3216 can be removed after inserting thepost through the hole in the suture tab.

In some embodiments, the adhesive pads 3206 can use a combination of anacrylic adhesive for the high stress points and a hydrocolloid adhesivefor long term securement and comfort. In some embodiments, the adhesivepads 3206 can use either the acrylic adhesive or the hydrocolloidadhesive. The backing layer 3216 can be made from paper, plastic or anyother suitable material that can be peeled from the adhesive. In someembodiments, a two or more securement devices 3200 can be disposed on asingle backing layer 3216 that can be perforated or scored between theadhesive pads 3206 of the securement devices 3200 to allow thesecurement devices 3200 to be held together during packaging and easyseparation of the securement devices 3200 from each other before use.The adhesive pad substrate can be a skin tone fabric or a clear materialthat allows for the skin color to show through in order to minimize thevisual impact of the device on the patient who may have to endure thecatheter for many days. The adhesive pad 3206 can be made of a flexiblematerial so that it can conform to that geometry of the patient's body.

FIGS. 32E-32G illustrate an embodiment of the engagement tab 3202 withthe backing layer removed. In addition, FIG. 32E illustrates across-sectional view of the engagement tab 3202 along a plane thatpasses through the groove 3214 and rail 3212 connection. The slidablegroove and rail connection can be provided with a locking feature, suchas a snap-lock feature that secures the cover 3210 over the base 3204 inthe closed configuration. The snap-lock feature can be made by, forexample, providing a rounded protrusion 3220 in the groove 3214 or slotand a matching or complementary rounded indentation 3222 in the rail3212. Alternatively, the rounded protrusion 3220 can be placed on therail 3212 and the rounded indentation 3222 can be placed on the groove3214. In the closed configuration, the rounded protrusion 3220 is placedwithin the rounded indentation 3222, thereby securing the cover 3210 inplace over the base 3204. The cover 3210 can be made of a flexiblematerial such that upon the application of force, the rails 3212 can bedisplaced outwards to free the rails from the locked position. To returnthe cover 3210 back to the locked position, force can be applied toslide the rails within the slot or groove until the rounded protrusion3220 snaps back into the rounded indentation 3222. In some embodiments,the locking feature provides a tactile and/or audible click to alert theoperator that cover 3210 has been moved to the locked or unlockedconfiguration. In addition, the base 3204 can be made of a differentcolor that the cover such that the operator is provided with a visualindicator of the open or close configuration of the cover 3210.

FIGS. 32H-32O illustrate various views of the cover 3210 and the base3204. In addition to the features described above, FIGS. 32I and 32M,illustrate a stop feature that prevents the cover 3210 from sliding offthe base 3204. The stop feature can also be integrated into the grooveand rail connection by, for example, providing a transversely extendingrail stop 3224 and a corresponding transversely extending groove stop3226 that are designed to abut against one another to stop furthermovement of the cover 3210 relative to the base 3204 when the cover 3210is at the fully opened configuration.

Because the securement device 3200 comes in modular parts, thesecurement device can accommodate catheter hubs of any width that usessuture tabs. This enables a universal fit for many catheter styles orbrands. As described above, a modular securement device 3200 providesmany benefits.

Attaching the engagement tab 3202 to the suture tab on the catheter is asimple maneuver that can be accomplished by simply engaging the post3208 of the engagement tab 3202 with the hole of the suture tab from thebottom up, as illustrated in FIG. 32P. The post 3208 can be exposed, ifcovered, by retracting the cover 3210 away from the catheter asdescribed above. This requires very little manipulation of theindwelling catheter which is a priority of users. Since the modularengagement tabs 3202 are independent, each engagement tab 3202 can beoptimally positioned sequentially according to the patient anatomy. Thislends flexibility of placement which is another important feature forusers. In addition, in some embodiments, the fit of the post 3208 withinthe hole of the suture tab can leave some room for the post 3208 topivot within the hole, which can further enhance the ability of themodular securement system to conform to the variable geometry of thepatient's body. This can be accomplished, for example, by making thepost 3208 have a smaller diameter than the hole of the suture tab. Theability of the engagement tabs 3202 to pivot on the suture tab allowsthe engagement tabs 3202 and catheter hub or other device to each liewithin different planes if needed, which aids the system in conformingto the patient's body. The adhesive pads 3206 of each engagement tab3202 can be trimmed to any shape if needed. Once both engagement tabs3202 are in place, the catheter is held extremely well by the adhesivepads 3206. The shape and placement of adhesive provides resistance tolateral and upwards pulling of the catheter or tubing, thereby ensuringproper securement of the catheter to the patient. In addition, after thepost 3208 of the engagement tab 3202 has been inserted through thesuture tab, the cover 3210 can be slid back over the base 3204 and post3208 to secure the suture tab within the engagement tab 3202. Thesliding action to lock the cover 3210 in place avoids downwards pressureto close the device which can reduce unwanted motion being transmittedto the indwelling catheter.

In some embodiments, the engagement tab 3202, and particularly the cover3210, can be dome shaped with curved surfaces. The dome can have acontinuously smooth surface or a non continuous smooth surface with aflattened top portion. In some embodiments, a dome with a continuouslysmooth surface can be more easily covered with an overdressing such thatpockets of air trapped between the overdressing and dome are reduced.The engagement tab 3202 can be made of a transparent material, such as atransparent plastic, that allows the user to visualize the post 3208through the cover 3210. The post 3208 can be made opaque so that it iseasier to visualize. For example, the post can be coated or made from anopaque material. The discrete shape and size of the dome permits fullvisualization of the catheter hub and skin entry point. The engagementtab 3202 can have a low profile which enables smooth placement ofoverdressings, such as Tegaderm™, over the catheter, catheter hub,and/or securement devices 3200. For example, the engagement tab 3202 canhave a height that is less than or equal to the height of the catheterand/or the catheter hub. This results in a securement device 3200 withoptional overdressing that is no higher than the catheter or catheterhub itself with no obtrusive bumps, housings, catch points and the likefor maximum patient comfort while reducing the likelihood ofaccidentally snagging and dislodging or removing the catheter, catheterhub and/or securement device 3200.

As described above in the other embodiments, the securement device 3200can be used to secure a variety of different catheters and be used witha variety of different adaptors and line management devices.

The foregoing descriptions of specific embodiments of the presentinvention have been presented for purposes of illustration anddescription. They are not intended to be exhaustive or to limit theinvention to the precise forms disclosed, and obviously manymodifications and variations are possible in light of the aboveteaching. For example, features described in one embodiment can be usedin another embodiment. The embodiments were chosen and described inorder to best explain the principles of the invention and its practicalapplication, to thereby enable others skilled in the art to best utilizethe invention and various embodiments with various modifications as aresuited to the particular use contemplated.

What is claimed is:
 1. A device for securing a medical device having asuture tab to a patient's body, the device comprising: a pad having afirst surface for facing a patient and a second surface opposed to thefirst surface; a tab receiving portion disposed on the second surface ofthe pad and along a side edge of the pad, the tab receiving portiondefining a cavity that is enclosed except for an opening along the sideedge, the opening being parallel to the side edge and perpendicular toan axis of the medical device when the suture tab of the medical deviceis disposed in the cavity, the cavity being enclosed along a side of thetab receiving portion that is opposite to the side edge; and adownwardly extending post that is coupled to and that extends from aninside top surface of the tab receiving portion towards the pad.
 2. Thedevice of claim 1, wherein the downwardly extending post is biased awayfrom the side edge.
 3. The device of claim 2, wherein the downwardlyextending post is biased at an angle between about 0 to 30 degrees fromthe vertical axis.
 4. The device of claim 1 , wherein the downwardlyextending post is configured to engage the suture tab.
 5. The device ofclaim 1, wherein the pad comprises an opening under the tab receivingportion that is configured to receive the suture tab.
 6. The device ofclaim 1, wherein the tab receiving portion is transparent.
 7. The deviceof claim 1, further comprising a backing layer disposed over an adhesiveon the first surface of the pad, wherein the backing layer comprises apull tab.
 8. The device of claim 7, wherein the backing layer comprisesa first portion disposed proximate the tab receiving portion and havinga first pull tab, and a second portion disposed away from the tabreceiving portion and having a second pull tab, wherein the firstportion and the second portion are separably removable.
 9. The device ofclaim 1, wherein the adhesive comprises a hydrocolloid adhesive.
 10. Thedevice of claim 9, wherein the adhesive further comprises an acrylicadhesive disposed on portions of the pad configured to be exposed tohigh stress.
 11. The device of claim 1, wherein the pad has skin tonecolor.
 12. The device of claim 1, wherein the pad is transparent. 13.The device of claim 1, wherein the tab receiving portion is shaped likea dome.
 14. The device of claim 13, wherein the dome has a continuouslysmooth surface.
 15. The device of claim 13, wherein the dome has aflattened top portion.
 16. The device of claim 1, wherein the tabreceiving portion has a height that is less than or equal to the heightof the medical device.
 17. A system for securing a medical device havinga first suture tab to a patient's body, the system comprising: a firstengagement tab comprising an pad having a first surface coated with anadhesive and a second surface, a tab receiving portion disposed on thesecond surface of the pad and along a side edge of the pad, and adownwardly extending post that extends from the top of the tab receivingportion towards the pad, wherein the downwardly extending post isconfigured for being disposed through the first suture tab, the tabreceiving portion defining a cavity that is enclosed except for anopening along the side edge, the opening being parallel to the side edgeand perpendicular to an axis of the medical device when the suture tabof the medical is disposed in the cavity, the cavity being enclosedalong a side of the tab receiving portion that is opposite to the sideedge.
 18. The system of claim 17, further comprising an overdressingcovering at least a portion of the first engagement tab and the medicaldevice.
 19. The system of claim 17, further comprising a secondengagement tab that is secured to a second suture tab on the medicaldevice, wherein the second engagement tab is secured independently ofthe first engagement tab.
 20. The system of claim 19, wherein the firstengagement tab is pivotably engaged with the first suture tab and thesecond engagement tab is pivotably engaged with the second suture tab.21. A system for securing a medical device to a patient's body, thesystem comprising: an adaptor having a first suture tab, wherein theadaptor is removably disposed disposable over a portion of the medicaldevice; and a first engagement tab comprising an pad having a firstsurface and a second surface, a tab receiving portion disposed on thesecond surface of the pad and along a side edge of the pad, and adownwardly extending post that extends from the top of the tab receivingportion towards the pad, wherein the downwardly extending post isdisposed through the first suture tab, the tab receiving portiondefining a cavity that is enclosed except for an opening along the sideedge, the opening being parallel to the side edge and perpendicular toan axis of the medical device when the suture tab of the medical deviceis disposed in the cavity, the cavity being enclosed along a side of thetab receiving portion that is opposite to the side edge.
 22. The systemof claim 21, further comprising an overdressing covering at least aportion of the first engagement tab, adaptor and the medical device. 23.The system of claim 21, further comprising a second engagement tab thatis secured to a second suture tab on the adaptor, wherein the secondengagement tab is secured independently of the first engagement tab. 24.The system of claim 21, wherein the adaptor comprises a channel forreceiving the portion of the medical device.
 25. The system of claim 21,wherein the channel comprises a deformable liner.
 26. The system ofclaim 21, wherein the deformable liner is elastic and reversiblydeformable.
 27. The system of claim 21, wherein the deformable liner ismade of foam.